This study will examine how a standard Tixel treatment versus a sham treatment for eye wrinkles affects the symptoms and signs of Dry Eye Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Participants will receive three Tixel® treatments at 2-weeks intervals
Participants will receive three sham treatments at 2-weeks intervals
Vision Science, School of Optometry
Birmingham, United Kingdom
RECRUITINGTo assess the safety of periorbital Tixel treatments in patients with dry eye through the reporting of adverse events (AE) and serious adverse events (SAE) exclusively.
SAFETY, number of AEs Any safety related event during the study will be recorded and analyzed
Time frame: Through study completion, an average of 4 months
To evaluate the impact of the treatment on symptoms and signs of dry eyes and compare the findings with those of a control group.
NIBUT Seconds OSDI Score Topography mm/ D Slit Lamp examination Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Lid margin profile Tear Sampling Analysis Ocular tear biomarkers Meibography Corneal staining with fluorescein Conjunctival staining with lissamine green
Time frame: Through study completion, an average of 4 months
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